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Amelogen Plus

by Ultradent Products, Inc.

510(k) K043119

Amelogen Plus is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K043119 on 17 Dec 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK043119 Date17 Dec 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K043119

74 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K043119
UDI-DISize and differences
Amelogen Plus 315
ULTRADENT PRODUCTS, INC.
315 / 31500883205036933
Single use: no
On the market
Amelogen Plus 315
ULTRADENT PRODUCTS, INC.
315 / 31500883205027320
Single use: no
On the market
Amelogen Plus 8010
ULTRADENT PRODUCTS, INC.
8010 / 801000883205106902
Single use: yes
On the market
Amelogen Plus 8011
ULTRADENT PRODUCTS, INC.
8011 / 801100883205036964
Single use: yes
On the market
Amelogen Plus 8012
ULTRADENT PRODUCTS, INC.
8012 / 801200883205106926
Single use: yes
On the market
Amelogen Plus 8014
ULTRADENT PRODUCTS, INC.
8014 / 801400883205036995
Single use: yes
On the market
Amelogen Plus 8014
ULTRADENT PRODUCTS, INC.
8014 / 801400883205106940
Single use: yes
On the market
Amelogen Plus 8016
ULTRADENT PRODUCTS, INC.
8016 / 801600883205037015
Single use: yes
On the market
Amelogen Plus 8017
ULTRADENT PRODUCTS, INC.
8017 / 801700883205037022
Single use: yes
On the market
Amelogen Plus 8019
ULTRADENT PRODUCTS, INC.
8019 / 801900883205037046
Single use: yes
On the market
Amelogen Plus 8019
ULTRADENT PRODUCTS, INC.
8019 / 801900883205106995
Single use: yes
On the market
Amelogen Plus 8021
ULTRADENT PRODUCTS, INC.
8021 / 802100883205037060
Single use: yes
On the market
Amelogen Plus 8022
ULTRADENT PRODUCTS, INC.
8022 / 802200883205107022
Single use: yes
On the market
Amelogen Plus 8026
ULTRADENT PRODUCTS, INC.
8026 / 802600883205107053
Single use: yes
On the market
Amelogen Plus 9030
ULTRADENT PRODUCTS, INC.
9030 / 903000883205037121
Single use: no
On the market
Amelogen Plus 9030
ULTRADENT PRODUCTS, INC.
9030 / 903000883205107107
Single use: no
On the market
Amelogen Plus 9034
ULTRADENT PRODUCTS, INC.
9034 / 903400883205037169
Single use: no
On the market
Amelogen Plus 9035
ULTRADENT PRODUCTS, INC.
9035 / 903500883205037176
Single use: no
On the market
Amelogen Plus 9037
ULTRADENT PRODUCTS, INC.
9037 / 903700883205107176
Single use: no
On the market
Amelogen Plus 9040
ULTRADENT PRODUCTS, INC.
9040 / 904000883205107206
Single use: no
On the market
Amelogen Plus 9041
ULTRADENT PRODUCTS, INC.
9041 / 904100883205037237
Single use: no
On the market
Amelogen Plus 9043
ULTRADENT PRODUCTS, INC.
9043 / 904300883205037251
Single use: no
On the market
Amelogen Plus 9043
ULTRADENT PRODUCTS, INC.
9043 / 904300883205107237
Single use: no
On the market
Amelogen Plus S3020
ULTRADENT PRODUCTS, INC.
S3020 / S302000883205101266
Single use: no
On the market

Other devices from Ultradent Products, Inc.

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